Reliability and validity of rapid assessment tools for measuring 24-hour movement behaviours in children aged 0-5 years: the Movement Behaviour Questionnaire Baby (MBQ-B) and child (MBQ-C).

BACKGROUND: The development of validated "fit-for-purpose" rapid assessment tools to measure 24-hour movement behaviours in children aged 0-5 years is a research priority. This study evaluated the test-retest reliability and concurrent validity of the open-ended and closed-ended versions of the Movement Behaviour Questionnaire for baby (MBQ-B) and child (MBQ-C). METHODS: 300 parent-child dyads completed the 10-day study protocol (MBQ-B: N = 85; MBQ-C: N = 215). To assess validity, children wore an accelerometer on the non-dominant wrist (ActiGraph GT3X+) for 7 days and parents completed 2 × 24-hour time use diaries (TUDs) recording screen time and sleep on two separate days. For babies (i.e., not yet walking), parents completed 2 × 24-hour TUDs recording tummy time, active play, restrained time, screen time, and sleep on days 2 and 5 of the 7-day monitoring period. To assess test-retest reliability, parents were randomised to complete either the open- or closed-ended versions of the MBQ on day 7 and on day 10. Test-retest intraclass correlation coefficients (ICC's) were calculated using generalized linear mixed models and validity was assessed via Spearman correlations. RESULTS: Test-retest reliability for the MBQ-B was good to excellent with ICC's ranging from 0.80 to 0.94 and 0.71-0.93 for the open- and closed-ended versions, respectively. For both versions, significant positive correlations were observed between 24-hour diary and MBQ-B reported tummy time, active play, restrained time, screen time, and sleep (rho = 0.39-0.87). Test-retest reliability for the MBQ-C was moderate to excellent with ICC's ranging from 0.68 to 0.98 and 0.44-0.97 for the open- and closed-ended versions, respectively. For both the open- and closed-ended versions, significant positive correlations were observed between 24-hour diary and MBQ-C reported screen time and sleep (rho = 0.44-0.86); and between MBQ-C reported and device-measured time in total activity and energetic play (rho = 0.27-0.42). CONCLUSIONS: The MBQ-B and MBQ-C are valid and reliable rapid assessment tools for assessing 24-hour movement behaviours in infants, toddlers, and pre-schoolers. Both the open- and closed-ended versions of the MBQ are suitable for research conducted for policy and practice purposes, including the evaluation of scaled-up early obesity prevention programs.

A great way to bring up health behaviour topics at playgroup: a qualitative evaluation of the Healthy Conversations @ Playgroup program.

BACKGROUND: The early years is a critical stage to establish optimal nutrition and movement behaviours. Community playgroups are a relaxed environment for parents with a focus on social connection and supporting parents in their role as 'First Teachers'. Playgroups are therefore an opportunistic setting to promote health behaviours in the early years. To support parents with young children around healthy lifestyle behaviours, the Healthy Conversations @ Playgroup program was delivered in urban and regional areas, across three Australian jurisdictions between 2021-2023. OBJECTIVE: This qualitative evaluation aimed to understand how the Healthy Conversations @ Playgroup program was experienced by parents, playgroup coordinators and peer facilitators. DESIGN: Semi-structured virtual interviews and focus groups were conducted with parents, playgroup coordinators (i.e., person responsible for coordinating the playgroup) and peer facilitators (i.e., trained facilitator for the program) that participated in the Healthy Conversations @ Playgroup study. Transcripts were analysed following a thematic analysis approach. RESULTS: Twenty-eight playgroup parents, coordinators or peer facilitators participated in one of 8 focus groups or 5 interviews. Four themes were developed: Program strengths and challenges; Setting strengths and challenges; Factors that impact program delivery; Participant's suggestions for future program delivery. CONCLUSIONS: The Healthy Conversations @ Playgroup program was valued by parents, providing validation and normalisation of parenting practices, and fostering a shared experience of parenting. Playgroups are a convenient setting for families to attend. The dynamic and distracting nature of the playgroup setting were carefully considered when designing the program. Strategies to further enhance program engagement could include use of coordinator or parent champions, tailored delivery, and extending the reach to other family members. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000055808, registered 22 January 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380890.

Goal-directed therapeutic exercise for paediatric posterior fossa brain tumour survivors: a qualitative analysis of experiences.

PURPOSE: To explore child and parent experiences of a 12-week goal-directed therapeutic exercise intervention in paediatric posterior fossa brain tumours survivors and to identify features of the program that influenced program adherence and acceptability. METHODS: Eleven interviews were conducted; five parent-child dyads (mothers = 83%) and one parent only (mean child age = 10.6 ± 3.0 years; 83% male). Posterior fossa brain tumour survivors, who participated in a weekly goal-directed exercise program for 12 weeks, completed semi-structured interviews to discuss their experience of the program. An inductive content analysis was undertaken. Interviews were transcribed, imported into NVivo and independently coded by two reviewers. Code and content categories were iteratively discussed and refined. RESULTS: Five content categories were generated: (1) perceived improvements, (2) program logistics, (3) activity selection, (4) connection with the therapist and (5) options for technology. All participants valued the tailored exercise program and described improvements in movement competence. Children and their parents discussed preferring home- and community-based locations and favoured face-to-face delivery. Occasionally, parents reported difficulty completing the home program due to low child motivation or family time restrictions. Multiple families suggested an interactive digital application would be an effective delivery channel for the supplemental home-based program. CONCLUSION: A goal-directed exercise program delivered at home and in community-based locations was considered valuable and helpful for improving movement competence in paediatric survivors of posterior fossa brain tumour. TRIAL REGISTRATION: ACTRN12619000841178 June 12, 2019.

Cognitive Testing of Items Measuring Movement Behaviours in Young Children Aged Zero to Five Years: Development of the Movement Behaviour Questionnaires for -Baby (MBQ-B) and -Child (MBQ-C).

This paper describes the cognitive interview phase of the development of two brief surveys, the Movement Behaviour Questionnaire-Baby (MBQ-B) and Movement Behaviour Questionnaire-Child (MBQ-C), which measure the duration of physical activity, screen time, and sleep of children aged 0-5 years. The aims were (1) review the format, content, and clarity of questionnaire items and response options, (2) understand how parents retrieve, encode, and formulate responses when asked about their child's movement behaviours, and (3) identify potential sources of response error and make appropriate modifications. Interviews with parents of children aged 0-5 years were conducted using concurrent think-aloud techniques and probing questions. Parents reviewed the MBQ-B and/or MBQ-C depending on the developmental stage of their child(ren). Twenty-nine interviews were conducted with 20 parents, over four iterative rounds. Participants recalled usual family routines and rules when estimating the duration/frequency of behaviours. To estimate active play, parents referred to the child's daily routine considering wake and bedtimes, naps, and mealtimes. Participants were influenced by the examples provided, being unable to interpret these as exemplars only. Decomposing general items into specific questions with examples was well received. Use of numeracy skills when estimating duration was evident. Interviews informed revisions to item wording, examples, and recall prompts, which will be taken forward into the MBQ-B and MBQ-C validation studies. Utilising cognitive interviewing can enhance confidence that questionnaire items are correctly interpreted and understood by participants.

Bronchiectasis - Exercise as Therapy (BREATH): rationale and study protocol for a multi-center randomized controlled trial.

BACKGROUND: Globally, bronchiectasis (BE) unrelated to cystic fibrosis (CF) is recognized as a major cause of respiratory morbidity, mortality, and healthcare utilization. Children with BE regularly experience exacerbations of their condition resulting in frequent hospitalizations and decreased health-related quality of life (HR-QoL). Guidelines for the treatment and management of BE call for regular exercise as a means of improving aerobic fitness and HR-QoL. Moreover, research in adults with BE has shown that exercise can reduce the frequency of exacerbations, a potent predictor of future lung function decline and respiratory morbidity. Yet, to date, the health benefits resulting from therapeutic exercise have not been investigated in children with BE. The BREATH, Bronchiectasis - Exercise as Therapy, trial will test the efficacy of a novel 8-week, play-based therapeutic exercise program to reduce the frequency of acute exacerbations over 12 months in children with BE (aged ≥ 4 and < 13 years). Secondary aims are to determine the cost-effectiveness of the intervention and assess the program's impact on aerobic fitness, fundamental movement skill (FMS) proficiency, habitual physical activity, HR-QoL, and lung function. METHODS: This multi-center, observer-blinded, parallel-group (1:1 allocation), randomized controlled trial (RCT) will be conducted at three sites. One hundred and seventy-four children ≥ 4 and < 13 years of age with BE will be randomized to a developmentally appropriate, play-based therapeutic exercise program (eight, 60-min weekly sessions, supplemented by a home-based program) or usual care. After completing the baseline assessments, the number of exacerbations and secondary outcomes will be assessed immediately post-intervention, after 6 months of follow-up, and after 12 months of follow-up. Monthly, parental contact and medical review will document acute respiratory exacerbations and parameters for cost-effectiveness outcomes. DISCUSSION: The BREATH trial is the first fully powered RCT to test the effects of a therapeutic exercise on exacerbation frequency, fitness, movement competence, and HR-QoL in children with bronchiectasis. By implementing a developmentally appropriate, play-based exercise program tailored to the individual needs of children with bronchiectasis, the results have the potential for a major paradigm shift in the way in which therapeutic exercise is prescribed and implemented in children with chronic respiratory conditions. The exercise program can be readily translated. It does not require expensive equipment and can be delivered in a variety of settings, including the participant's home. The program has strong potential for translation to other pediatric patient groups with similar needs for exercise therapy, including those with obesity, childhood cancers, and neurological conditions such as cerebral palsy. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Register (ANZCTR) ACTRN12619001008112.

Dietary and Physical Activity Changes and Adherence to WCRF/AICR Cancer Prevention Recommendations following a Remotely Delivered Weight Loss Intervention for Female Breast Cancer Survivors: The Living Well after Breast Cancer Randomized Controlled Trial.

BACKGROUND: Diet, exercise, and weight management are key in improving outcomes for breast cancer survivors, with international recommendations for cancer survivors relating to these behaviors. However, few behavioral interventions have reported outcomes aligned specifically with these recommendations. OBJECTIVE: To evaluate a remotely delivered weight loss intervention vs usual care for female breast cancer survivors, on changes in multiple diet and physical activity behaviors. DESIGN: A randomized controlled trial with assessments at study baseline, 6-, 12-, and 18 months (ie, mid-intervention, post-intervention, and non-contact follow-up). PARTICIPANTS/SETTING: Participants were recruited between October 2012 and December 2014 through hospitals in Brisbane, Australia, and the state-based cancer registry. Eligible participants (women aged 18 to 75 years with body mass index 25 to 45 kg/m2 who were diagnosed with stage I through III breast cancer during previous 2 years) were randomly allocated to intervention (n = 79) or usual care (n = 80). INTERVENTION: Participants randomized to the intervention group received 22 counseling telephone calls targeting diet and physical activity aimed at achieving 5% to 10% weight loss, and optional text messages, over 12 months. Usual care participants received their standard medical care and brief feedback following each assessment, which was similar to that provided to intervention participants with the exception that usual care participants' results were not compared with national and study recommendations. MAIN OUTCOME MEASURES: Dietary intake (24-hour recalls), physical activity (hip-worn GT3X+ accelerometer [Actigraph]), sitting time (thigh-worn activPAL3 [PAL Technologies Limited), and adherence to World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendations for cancer survivors (0 to 7 score) were measured at each assessment, with data collected between November 2012 and October 2016. STATISTICAL ANALYSES PERFORMED: Intervention effects were assessed by linear mixed models, accounting for repeated measures and baseline values. Significance was set at P < 0.05. RESULTS: At baseline, participants were aged 55 ± 9 years, with a body mass index of 31.4 ± 5.0 kg/m2, 10.7 ± 5.0 months postdiagnosis, and primarily non-minority. At baseline, only 8% (n = 12) of participants met ≥5 out of seven WCRF/AICR recommendations (WCRF/AICR adherence score = 3.8 ± 1.0). At 12 months, significant intervention effects were observed in walking/running (+21 minutes/week; 95% CI 4 to 38) and WCRF/AICR adherence scores (+0.3 points; 95% CI 0.0 to 0.6) only. At 18 months, significant intervention effects were observed for energy intake (-229 kcal/day energy; 95% CI -373 to -84), total fat (-10 g/day; 95% CI -18 to -2), and saturated fat (-5 g/day; 95% CI -9 to -1), and were sustained for WCRF/AICR adherence scores (+0.5 points; 95% CI 0.2 to 0.8). CONCLUSIONS: This remotely delivered weight loss intervention led to sustained improvements in WCRF/AICR adherence scores, and some improvements in diet and physical activity. These findings provide support for the health benefit of programs targeting lifestyle behaviors in line with cancer survivor recommendations, and the potential for dissemination of such programs for women following treatment for early-stage breast cancer.

Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial.

Limited evidence exists on the effects of weight loss on chronic disease risk and patient-reported outcomes in breast cancer survivors. Breast cancer survivors (stage I-III; body mass index 25-45 kg/m2) were randomized to a 12-month, remotely delivered (22 telephone calls, mailed material, optional text messages) weight loss (diet and physical activity) intervention (n = 79) or usual care (n = 80). Weight loss (primary outcome), body composition, metabolic syndrome risk score and components, quality of life, fatigue, musculoskeletal pain, menopausal symptoms, fear of recurrence, and body image were assessed at baseline, 6 months, 12 months (primary endpoint), and 18 months. Participants were 55 ± 9 years and 10.7 ± 5.0 months post-diagnosis; retention was 81.8% (12 months) and 80.5% (18 months). At 12-months, intervention participants had significantly greater improvements in weight (-4.5% [95%CI: -6.5, -2.5]; p < 0.001), fat mass (-3.3 kg [-4.8, -1.9]; p < 0.001), metabolic syndrome risk score (-0.19 [-0.32, -0.05]; p = 0.006), waist circumference (-3.2 cm [-5.5, -0.9]; p = 0.007), fasting plasma glucose (-0.23 mmol/L [-0.44, -0.02]; p = 0.032), physical quality of life (2.7 [0.7, 4.6]; p = 0.007; Cohen's effect size (d) = 0.40), musculoskeletal pain (-0.5 [-0.8, -0.2]; p = 0.003; d = 0.49), and body image (-0.2 [-0.4, -0.0]; p = 0.030; d = 0.31) than usual care. At 18 months, effects on weight, adiposity, and metabolic syndrome risk scores were sustained; however, significant reductions in lean mass were observed (-1.1 kg [-1.7, -0.4]; p < 0.001). This intervention led to sustained improvements in adiposity and metabolic syndrome risk.

Study protocol for Healthy Conversations @ Playgroup: a multi-site cluster randomized controlled trial of an intervention to promote healthy lifestyle behaviours in young children attending community playgroups.

BACKGROUND: Early childhood is a critical window for preventing obesity and chronic disease. Yet, 1 in 4 Australian children aged 5 years and under are affected by overweight or obesity; and significant proportions of children under 5 years fail to meet guidelines for diet quality, physical activity (PA), screen time, and sleep. Consequently, effective interventions to promote healthy lifestyle behaviors and prevent obesity during early childhood are needed. Community playgroups provide an opportunity for parents, carers, and children to meet in a safe and relaxed environment to play and share information. The structure, low cost and reach of playgroups provide a unique platform to engage parents in a scalable program to promote healthful lifestyle behaviors and prevent childhood obesity. However, the evidence base for the effectiveness of health promotion programs delivered in community playgroup settings is limited and lacking credible evidence from rigorously conducted randomized controlled trials. METHODS: The Healthy Conversations @ Playgroup randomized controlled trial (RCT) aims to address the underlying behavioral risk factors for obesity by helping parents take effective steps to improve their child's dietary, PA, screen time, and sleep behaviors. The intervention program comprises 10 "healthy conversations" led by a trained peer facilitator, designed to increase parents' behavioral capability and self-efficacy to implement autonomy-supportive parenting practices. The program will be delivered biweekly during regularly scheduled playgroup sessions over 10-weeks. Effectiveness will be tested in a 2-arm cluster RCT involving 60 community playgroups in three states across Australia. After baseline assessments, participating playgroups will be randomly allocated to either intervention or wait-list control conditions. Primary outcomes (vegetable intake, discretionary foods, daily PA, screen time, sleep duration, and body mass index [BMI] z-score) will be assessed at baseline, immediately post-intervention (10-weeks; T2) and 6-months post-intervention (T3). Outcomes will be assessed for differential change at T2 and T3. DISCUSSION: The Healthy Conversations @ Playgroup trial will rigorously evaluate a novel peer-led intervention program to promote healthful lifestyle behaviors and prevent obesity in children and families attending community playgroups. If effective, the program could be immediately scaled-up and delivered in community playgroups across Australia. TRIAL REGISTRATION: Trial registered 22nd January 2021 with the Australian and New Zealand Clinical Trials Registry ( ACTRN12621000055808 ).

Measurement of screen time among young children aged 0-6 years: A systematic review.

The impact of screen-based devices on children's health and development cannot be properly understood without valid and reliable tools that measure screen time within the evolving digital landscape. This review aimed to summarize characteristics of measurement tools used to assess screen time in young children; evaluate reporting of psychometric properties; and examine time trends related to measurement and reporting of screen time. A systematic review of articles published in English across three databases from January 2009 to April 2020 was undertaken using PROSPERO protocol (registration: CRD42019132599) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Included articles measured screen time as outcome, exposure, or confounder in children 0-6 years. The search identified 35,868 records, 1035 full-text articles were screened for eligibility, and 622 met inclusion criteria. Most measures (60%) consisted of one to three items and assessed duration of screen time on a usual day. Few measures assessed content (11%) or coviewing (7%). Only 40% of articles provided a citation for the measure, and only 69 (11%) reported psychometric properties-reliability n = 58, validity n = 19, reliability and validity n = 8. Between 2009 and 2019, the number of published articles increased from 28 to 71. From 2015, there was a notable increase in the proportion of articles published each year that assessed exposure to mobile devices in addition to television. The increasing number of published articles reflects increasing interest in screen time exposure among young children. Measures of screen time have generally evolved to reflect children's contemporary digital landscape; however, the psychometric properties of measurement tools are rarely reported. There is a need for improved measures and reporting to capture the complexity of children's screen time exposures.

Physical ACTivity in Survivorship (PACTS): study protocol for a randomized controlled trial evaluating a goal-directed therapeutic exercise program in pediatric posterior fossa brain tumor survivors.

BACKGROUND: Posterior fossa brain tumors (PFBT) are the most common solid tumor in children. Recent increases in survival rates are encouraging; however, survivors may experience a plethora of disease- and treatment-related complications that can persist into adulthood. Therapeutic exercise interventions have been shown to improve quality of survivorship in other pediatric cancer diagnoses. There is also evidence that goal-directed interventions are effective at improving motor activities, function, and self-care in children with complex health conditions. Yet, there is currently no evidence on the efficacy of goal-directed therapeutic exercise in pediatric PFBT survivors. The Physical ACTivity in Survivorship (PACTS) study aims to investigate the effects of a novel goal-directed therapeutic exercise program on cardiorespiratory fitness and physical activity-related goal attainment in pediatric survivors of PFBT. METHOD: PFBT survivors, aged five to 17 years, who underwent surgery at least 12 months earlier and completed radiation therapy and/or chemotherapy at least 6 months prior will be recruited from the Queensland Children's Hospital (Brisbane, Australia) (target n = 48). Following baseline assessment, participants are randomized into either the intervention or usual care group. The intervention group will receive weekly individualized, goal-directed exercise therapy delivered face-to-face for 12 weeks, along with an accompanying home-based program (three sessions per week). Outcomes will be assessed at baseline, immediately post-intervention, and at 6- and 12-months post-intervention. The primary outcomes are cardiorespiratory fitness (Peak VO2) and physical activity-related goal attainment. Secondary outcomes are cardiorespiratory endurance, high-level mobility skills, functional muscle strength, habitual physical activity, gait, balance, quality of life, fatigue, participation, perceived movement skill competence and parameters of body composition. DISCUSSION: PACTS is the first study to investigate the efficacy of goal-directed therapeutic exercise in children with PFBT and provide evidence needed to inform clinical practice recommendations for managing quality of survivorship in PFBT survivors. TRIAL REGISTRATION: ACTRN12619000841178 .

Overall Dietary Intake and Prognosis after Breast Cancer: A Systematic Review.

Breast cancer survivors often seek information about how lifestyle factors, such as diet, may influence their prognosis. Previous studies have reviewed evidence around single nutrients, individual foods or food groups. We reviewed studies examining relationships between overall dietary intake and prognosis in breast cancer survivors. A systematic search was conducted to identify studies, published until June 2016, which assessed associations between overall dietary intake (i.e., quality; score; pattern) and mortality and/or recurrence in breast cancer survivors. We identified seven eligible studies. Studies were heterogeneous regarding diet assessment timing (before/after diagnosis); mean age and menopausal status; and dietary intake measure (statistically derived/a priori defined indices). Better overall dietary intake (i.e., better quality; healthy/prudent pattern; less inflammatory diet) was associated with decreased risk of overall and non-breast cancer mortality, in most studies. Insufficient evidence is available to draw conclusions regarding breast cancer-specific survival and disease recurrence. Following breast cancer diagnosis, better overall dietary intake may independently improve overall and non-breast cancer survival. Survivors may improve prognosis by adopting more healthful dietary patterns consistent with dietary guidelines and/or prudent diet. Future adequately powered studies should consider measuring dietary intake consistently to better understand the role of diet in disease-specific outcomes.

Breast cancer survivors' experience of making weight, dietary and physical activity changes during participation in a weight loss intervention.

PURPOSE: The aim of this study is to explore breast cancer survivors' experience of a weight loss intervention and identify potential facilitators and barriers of initiating and maintaining weight, dietary or physical activity changes. METHOD: Fourteen women randomised to and completing the 12-month weight loss intervention completed semi-structured interviews 7.5 ± 0.5 months after intervention completion. An inductive thematic analysis was conducted whereby interviews were independently coded and themes identified. RESULTS: Women were (mean ± SD) 55.6 ± 8.5 years, 30.2 ± 4.6 kg/m2 and 17.1 ± 3.4 months post-diagnosis at study baseline. Four themes emerged: (1) perceived motivation to participate in the intervention, (2) facilitators, (3) challenges and (4) maintenance of weight loss and behaviour changes. All women noted the impact of social/family environments, either to facilitate (e.g., support from family members) or impede (e.g., major family event) changes. The structure and support of the intervention, particularly accountability to their coach, was also seen as facilitating. Formation of habitual physical activity facilitated dietary changes. Dietary change strategies most perceived to facilitate weight loss were reducing energy intake by dietary self-monitoring, increasing vegetable intake and portion control. Challenges included breast cancer-specific issues such as post-diagnosis weight gain, treatment-related side effects and psychological issues around readiness to change and self-regulation. Diminished accountability following intervention completion impacted the maintenance of weight loss and behaviour changes, notably dietary self-monitoring. CONCLUSIONS: Results suggest that formal involvement of a support person (e.g. family member/friend) and referring women to ongoing, community-based services to maintain patient-perceived accountability may be particularly useful strategies for future weight loss intervention trials targeting women with breast cancer.

Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

BACKGROUND: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. METHODS/DESIGN: Women (18-75 years; body mass index 25-45 kg/m2) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. DISCUSSION: This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ANZCTR) - ACTRN12612000997853 (Registered 18 September 2012).